FDA WARNING_LETTER - Denison Pharmaceuticals, LLC - February 09, 2023

The FDA issued a Warning Letter to Denison Pharmaceuticals, LLC, following an inspection from January 5 to February 9, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations. The facility's drug products are deemed adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate lubricant contamination (non-food grade lubricant used for months, impacting over 60 batches including infant products), multiple foul odor complaints for a product (with TNTC yeast and mold, and *Staphylococcus epidermis* identified, yet deemed "fit for use" without market action), and numerous microbiological excursions in the purified water system (TNTC bacteria, lack of root cause, and impact assessment). 2. **Lack of Component Identity Testing (21 CFR 211.84(d)(1)):** Failure to test high-risk components like glycerin and propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) contamination, which can cause lethal poisoning. 3. **Unvalidated Test Methods (21 CFR 211.165(e)):** Failure to validate alternative rapid microbiological test methods, specifically the (b)(4) system, which showed failing results for total count and objectionable microorganisms (e.g